MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-01 for SIDEXIS 4 6618735 manufactured by Sirona Dental Systems Gmbh.
[184708034]
The investigation from the r&d department has resulted: sidexis 4 is used in combination with sidicom wls and a central pacs system. Sidicom wls is configurated to send automatically the images to the pacs system after the acquisition. Multiple sidexis 4 users at one windows pc's with individual user accounts logged-in, in parallel. After an examination the user does no logout of his windows session and a different user starts with his additional log-in. Additionally, sidexis 4 is not closed from the previous user. If the above listed conditions are given the issue described will occur. The immediate action is to add an additional instruction into the sidicom wls packages that are shipped. Further capa action is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[184708035]
X-ray images were additionally linked to wrong patient record.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614977-2020-00001 |
| MDR Report Key | 9656563 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-01 |
| Date of Report | 2020-01-31 |
| Date Mfgr Received | 2020-01-16 |
| Date Added to Maude | 2020-02-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KARL NITTINGER |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494424 |
| Manufacturer G1 | SIRONA DENTAL SYSTEMS GMBH |
| Manufacturer Street | FABRIKSTRASSE 31 |
| Manufacturer City | BENSHEIM, D-64625 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-64625 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIDEXIS 4 |
| Generic Name | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
| Product Code | LLZ |
| Date Received | 2020-02-01 |
| Catalog Number | 6618735 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIRONA DENTAL SYSTEMS GMBH |
| Manufacturer Address | FABRIKSTRASSE 31 BENSHEIM, D-64625 GM D-64625 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-01 |